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Exporting Add-On for Medical Devices to the US - FDA Requirements

J

Jojo63

#1
Hi,

We will develop add-ons medical devices. These add-ons will be linked to a type of medical devices used for self-medication and the patient used to monitor treatment. These add-ons will have no impact on the dosage or length of treatment. They give any advice on what to do (eg. I reduce my treatment, I increase the intervals...). It is also expected that these add-ons send information to the Smartphone via Bluetooth.

If you want to export to the United States these additives, which rules should we follow? Should we have the FDA approval?

I think also at FCC for communications?

Thank you for your comments.


Jojo
 
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